A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure

NCT ID: NCT05904769

Last Updated: 2025-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-07-31

Brief Summary

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The purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ECG) readings on the LIFELEAF Smartwatch compared to standard methods of measurement.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Hospitalized Diabetic Group

Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, will wear the LIFELEAF Smartwatch for the duration of their hospital stay.

Group Type EXPERIMENTAL

LIFELEAF Smartwatch

Intervention Type DEVICE

Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.

Electrophysiologic (EP) Group

Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.

Group Type EXPERIMENTAL

LIFELEAF Smartwatch

Intervention Type DEVICE

Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.

Interventions

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LIFELEAF Smartwatch

Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.
* Patients undergoing continuous monitoring for heart rate, ECG and blood pressure as part of their routine care.
* Patients undergoing invasive and noninvasive electrophysiologic procedures.

Exclusion Criteria

* Patients unable to provide informed consent.
* Patients without arms as these are needed to wear the wrist-based sensor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Narayan (Guru) G. Kowlgi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Narayan Guru G. Kowlgi, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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22-010799

Identifier Type: -

Identifier Source: org_study_id

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